Senior Quality Assurance Specialist

6 days ago


Conshohocken, Pennsylvania, United States Extremity Care Full time

At Extremity Care, we are seeking a highly skilled Senior Quality Assurance Specialist to join our team. In this critical role, you will be responsible for ensuring the highest standards of quality in all aspects of our operations.

Job Overview:

This is an exciting opportunity for a seasoned professional to take on new challenges and contribute to the success of our organization. As a Senior Quality Assurance Specialist, you will be responsible for verifying operational compliance with regulatory requirements and industry standards, and ensuring that all products and services meet established quality standards.

Responsibilities:

  • Conduct thorough investigations into quality events, including deviations, non-conformances, CAPAs, customer complaints, SCARs, etc.
  • Leverage expertise to support coordination and execution of training/re-training and corrective/preventive actions associated with quality events.
  • Analyze data and trends to identify areas for improvement and drive process enhancements.
  • Evaluate suppliers to ensure their qualifications meet our quality standards.
  • Support internal and external audits to ensure compliance with regulatory requirements and industry standards.
  • Develop and revise procedures/controlled documents according to FDA, AATB, and other applicable regulations.
  • Review equipment, process, and software qualification, verification, and/or validation plans, execution data, and summary reports.
  • Assess quality control records, including equipment cleaning/maintenance, environmental monitoring, and supply inspections.
  • Trend and analyze Environmental Monitoring Results in accordance with standard operating procedures.
  • Audit and revise standard operating procedures in accordance with relevant regulations/standards, and internal organizational policies and standard operating procedures.
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB Standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
  • Promote a culture of quality awareness and continuous improvement within the organization.

Requirements:

  • Bachelor's degree in biological science, engineering, or related field from an accredited college or university.
  • At least 2-4 years of experience in an FDA-regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field.
  • At least 1 year of experience in conducting quality investigations and/or audits.
  • Clearance of favorable background investigation.

About Us:

Extremity Care is a leading provider of [industry/service] solutions. Our mission is to deliver exceptional quality and value to our customers while fostering a culture of innovation and excellence.

What We Offer:

  • Competitive salary range: $63,000 - $71,000 per annum.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.

How to Apply:

Please submit your application, including your resume and cover letter, to our online portal. We thank all applicants for their interest; however, only those selected for an interview will be contacted.



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